Clinical trials are the most reliable means for scientifically rigorous evaluation of the efficacy and safety of drugs, and are the most crucial part receiving the most investment in development and innovation in the pharmaceutical industry. In recent years, the nation has formulated a set of policies and guiding principles to encourage pharmaceutical innovation, promote the independent innovation of China’s pharmaceutical industry and enhance clinical trial capacity. To further improve Chinese researchers’ ability to perform clinical trials, the National Clinical Research Center for Cardiovascular Diseases, Fuwai Hospital, Chinese Academy of Medical Sciences and the National Center for Cardiovascular Diseases invited a multi-disciplinary team of experts from various areas including clinical trial methodology and supervision to work on this consensus. In view of the common concern and puzzles regarding the issues in clinical trials, such as recruitment and retention of participants, outcome selection, quality control, information technology application, and ethics in data security, the expert consensus is based on domestic and international guidelines, the latest advancement of clinical research, and the advice and opinions from national experts. It aims to provide reference information and guidance for clinical trial researchers, and serves as a reference for relevant authorities to formulate clinical trial management policies.
Ocular trauma is the most common cause of monocular vision loss in children. Among the patients with eye trauma in China, 15%-20% are children. The complexity of diagnosis and treatment and the uncertainty of prognosis are high because the ocular tissue of children is not fully developed and the history collection and examination are difficult. In order to further standardize the treatment of children's eye trauma and improve the treatment level, China Ocular Trauma Society has formulated Expert consensus of the treatment of pediatric ocular trauma in China by combining domestic and foreign literature and the actual medical situation in China. This consensus provides detailed recommendations on the classification, cause of injury, history collection, examination methods, diagnosis and treatment principles of pediatric eye trauma. This consensus applies to Chinese ophthalmologists and medical personnel engaged in the treatment of children's eye trauma, aiming to provide scientific guidance for the diagnosis and treatment of children's eye trauma, assist clinical decision-making, and further improve the treatment level of children's eye trauma in China.
Glycogen storage disease type Ib (GSD Ib) is a rare disorder of glycogen metabolism, often complicated by neutropenia/neutrophil dysfunction, leading to recurrent infections and the development of inflammatory bowel disease (IBD), which severely impacts patients’ quality of life. Empagliflozin, an SGLT2 inhibitor, has demonstrated the ability to restore neutrophil counts and function, thereby improving the immunodeficiency state in GSD Ib patients. This consensus aims to provide clinical practice recommendations for the use of empagliflozin in GSD Ib based on current evidence and expert experience. The purpose of this document is to outline these key points and offer guidance for the clinical application of empagliflozin in GSD Ib.
COVID-19 has been an established and continuing health problem. For the first time, this consensus focused on multi-scenario populations in the home/community, hospitalization and rehabilitation periods, and addressed medical nutrition management issues on which no consensus had yet been reached. This consensus was formulated on the basis of a comprehensive review of the existing evidence combined with the opinions of experts, with a view to complementing the existing guidelines/consensus.
Acute Retinal Necrosis Syndrome (ARN) is a severe, vision-threatening ocular disease caused by herpesvirus infections. It is characterized by abrupt onset and rapid progression, often leading to irreversible visual impairment due to complications in the affected eye such as rhegmatogenous retinal detachment, optic atrophy, and intractable hypotony—and potential involvement of the fellow eye if not promptly diagnosed and treated. As ARN is relatively uncommon, many ophthalmologists lack sufficient experience in diagnosing ARN. In addition, its management is complex, typically involving antiviral therapy, corticosteroids, and vitrectomy. Currently, diagnostic and therapeutic approaches to ARN in hospitals across China are largely based on individual clinical experience, underscoring the urgent need for a standardized clinical protocol. To address this, the Fundus Diseases Group in Ophthalmology Branch of Chinese Medical Association and the Professional Committee of Fundus Diseases in Ophthalmology Branch of Chinese Medical Doctor Association have jointly developed Expert consensus on the diagnosis and treatment of acute retinal necrosis syndrome. The consensus is informed by a comprehensive review of the literature, the latest clinical research findings, and consideration of the current socio-economic context in China. Following multiple rounds of expert review and revision, the final version has been completed. This document provides a detailed account of ARN, covering clinical manifestations, imaging and etiological assessments, diagnostic and differential diagnostic criteria, as well as medical and surgical treatment strategies. It is intended to serve as a practical guide for both subspecialized and general ophthalmologists. Developed in accordance with the principles of evidence-based medicine and adapted to China's clinical realities, the consensus offers practical guidance for the diagnosis and management of ARN. While the proposed clinical pathway is designed to meet the needs of most patients, clinicians are encouraged to tailor treatment plans based on individual patient factors, including disease severity, therapeutic options, and economic considerations.
Proliferative diabetic retinopathy (PDR) is more advanced stage in diabetic retinopathy (DR), often with vitreous hemorrhages and traction retinal detachment which seriously affects patients' vision and even leads to severe visual impairment. Pars plana vitrectomy is an effective treatment for PDR. However, the operation procedure is quite complexed. Inadequate management can negatively impact postoperative vision or even lead to complications. Therefore, it is very important to clarify the surgical indications and standardize the operating procedures of PDR. To this end, Fundus Disease Group of Ophthalmological Society of Chinese Medical Association, Fundus Disease Group of Ophthalmologist Branch of Chinese Medical Doctor Association, Expert Group of Expert consensus for pars plana vitrectomy treatment of type 2 diabetic retinopathy focus on 9 key clinical issues, based on the latest evidence-based medical evidence, combined with international guidelines and China's social and economic development. Recommendations were made on the selection of DR Surgery timing, perioperative blood glucose management, surgical mode selection, formulation of surgical operation plan, drug combination or laser therapy, etc., which formed China's expert consensus on pars plana vitrectomy in the treatment of type 2 DR. This consensus is applicable to Chinese doctors specializing in fundus diseases and doctors engaged in fundus diseases, aiming to provide scientific guidance for vitreous surgery treatment of PDR patients, assist clinical decision-making, and further improve the level of surgical treatment of DR in China.
Choroideremia (CHM) is a rare X-linked recessive genetic inherited degeneration. Affected males present with progressively worsening night blindness, visual field loss, and decreased central vision, which can cause blindness in middle age. Although female carriers typically exhibit mild symptoms, it is essential to understand their clinical features for early diagnosis of patients as well as genetic counseling of family members. The pathogenesis of CHM remains incompletely understood, and currently there is no approved effective treatment. To enhance clinicians’ comprehension of CHM and establish standardized clinical approaches to its diagnosis and management, the Chinese Hereditary Ocular Disease Diagnosis and Treatment Group and the Chinese Hereditary Ocular Disease Alliance assembled authoritative experts, through in-depth discussions, formed China's standardized recommedations for the on clinical diagnosis and treatment of CHM. The purpose of this advice is to provide a standardized diagnostic framework, monitoring indicators, and an integrated management strategy for clinicians to use in practice, thereby optimizing the care and genetic guidance for patients with CHM.
The population of various fundus diseases in China is vast, and the number of patients is continuously increasing due to the aging population. In contrast, fundus disease awareness among the general public in China is low, and grassroots screening needs urgent improvement. At the same time, the diagnosis and treatment rate are quite low, and the treatment methods for late-stage diseases are limited, resulting in poor prognosis of visual function and high blindness rate. Chronic fundus diseases require long-term, standardized treatment and long-term follow-up, which can be burdensome for patients, leading to high missed visit rates and reduced therapeutic effects. The "14th Five-Year Plan for Eye Health (2021-2025)" clearly put forward the requirements of strengthening the construction of the fundus disease prevention and control system. We urgently need to develop a management model for chronic diseases of fundus diseases tailored to China's national conditions. This will require establishing corresponding management platforms, improving personnel allocation, and enhancing compliance in the treatment of fundus diseases, to improve treatment effectiveness and fundamentally reduce blindness rates. After China's authoritative experts in the field of fundus diseases through the organization of in-depth and comprehensive thematic discussion, and the use of the improved version of Delphi method for collective decision-making and opinion consultation, a series of consensus guidance and suggestions were finally formed. These valuable professional insights will strongly promote the establishment of an appropriate chronic fundus disease management system in China, ensure that patients with fundus disease get long-term, standardized medical services, and lay a solid foundation for improving the overall prevention and treatment of fundus diseases.
Meige Syndrome (MS) is a neurological disorder characterized by blepharospasm, oromandibular dystonia, and spasmodic torticollis as its primary clinical manifestations. With advancements in neuroscience research and the accumulation of clinical experience, significant progress has been made in understanding the pathophysiological mechanisms, diagnostic criteria, and therapeutic strategies for MS both domestically and internationally. To standardize clinical practice and promote academic development, Neuro-ophthalmology Group of Ophthalmology Branch of Chinese Medical Association, in collaboration with Neuro-ophthalmology Society, Chinese Research Hospital Association, organized a panel of authoritative experts. This expert panel conducted a comprehensive review of the latest research evidence and clinical experiences. Through multiple rounds of expert consultations and in-depth discussions, the original consensus was thoroughly revised and updated. The new consensus aims to provide standardized diagnostic and treatment guidelines for clinicians, foster research innovation and the development of therapeutic techniques in the field of neuro-ophthalmology, address new challenges in the diagnosis and treatment of MS, and ultimately improve patients' quality of life.
Anti-tumor necrosis factor-α monoclonal antibody agents have been widely applied in the management of autoimmune diseases. Among them, Adalimumab and Infliximab have been used for years in clinical practice in treating non-infectious uveitis and achieved satisfactory effects and safety. However, no guideline or expert consensus for their usage is available in China currently. It hopefully promotes standardized clinical application of anti-tumor necrosis factor -α monoclonal antibody in treating non-infectious uveitis, together with other senior experts in uveitis, the Ocular Immunology Group of Immunology and Rheumatology Academy in Cross-Straits Medicine Exchange Association form this evidence-based recommendations for clinicians’ reference.